(Contractor) Senior Quality Control Microbiology Technician

Summary of Position

Perform assigned quality control activities within the Microbiology Department to comply with applicable SOP's and cGMPs. Work under limited supervision with considerable latitude for the use of initiative and independent judgment. Must have the ability to work collaboratively, multitask, and adapt to changing priorities and schedules.

Schedule: Monday - Friday 4pm - 12:30am (occasional off shift, weekend, and holiday work required).

Essential Functions

• Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).
• Employ aseptic techniques while performing Sterility, Endotoxin, Particulates and Bioburden testing of drug products, intermediates and raw materials per USP and Curium Standard Operating Procedures (SOP) 
• Perform in vivo biological performance testing of final product in support of product efficacy and quality per USP and Curium Standard Test Methods
• Perform Growth Promotion testing per USP Methods for various microbiological media.
• Prepare and analyze Biological Indicators in support of Validation and Qualification activities.
• Read plates to quantify microbial growth and subculture pure isolates as required.
• Data entry and review in Laboratory Management Systems (LIMS).
• General laboratory housekeeping duties and maintenance of the department, premises, and equipment.
• Collaborate with other team members to ensure the consistent and timely completion of all testing and other tasks in support of business needs.
• Assist with laboratory investigations, root cause analysis, and implementation of corrective and preventative actions.
• Ensure a safe and quality-minded working environment through conformance with training, general awareness, and compliance to safety/Quality guidelines and SOPs.
• Perform all work in compliance with site safety and radiation protection guidelines.
• Attend mandatory trainings as required by site regulatory requirements and management.
• Perform other general duties associated with the position as required by supervision.
• Management of inventory and ensuring all laboratory supplies are appropriately stocked.
• Assist in monthly equipment safety inspections.
• Assist in the training of less experienced technicians.
• Perform alert recovery trending.
   

Requirements

• Associate Degree or completion of 4 college-level life science courses required. Work experience is considered in lieu of degree.
• 3 or more years of relevant experience required.
• Willingness to perform in vivo testing in support of product efficacy and quality.
• General quality / production experience in a cGMP regulated facility is required.
• Good interpersonal skills, good hands on, analytical, problem solving and decision-making skills.
• Excellent writing and verbal communications skills
• Close attention to detail required.
• Good computer skills, including utilizing personal computers and data entry programs.
• Ability to work independently and with others to accomplish goals and priorities.
• Flexibility and teamwork skills.
• High level of energy and regular, consistent attendance.

Working Conditions:

• Willingness to work in plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.
• Responsibilities include the ability to lift up to 70 pounds, kneeling, crouching, twisting the upper body, walking, bending, stooping, pushing, pulling, reaching, must be able to physically negotiate stairs and evacuation ladders with or without accommodation, wear and operate safety equipment, enter vessels, and inspect equipment.  
• Material handling devices (e.g., hand truck, fork truck, and conveyors) are used when possible, however, use of proper lifting and movement techniques is necessary to prevent injury.
• Must be willing to wear a variety of Personal Protective Equipment (PPE) and hearing protection as needed.
• May be required to sit or stand for long periods of 8+ hours a day while performing duties.  
• Must possess good hand-eye coordination; close attention to detail is required.
• Must be able to work indoors and outdoors with exposure to mechanical/moving parts, hazards including corrosive, flammable and toxic material, dust, dirt, odors, and irritants. 
• Willingness to complete safety training within allotted timeframes, and work in a team-based environment.
• Must be able to work outside of regular work hours, including off shift, weekend, and holiday work as business needs require.